变更药用辅料前后的七味清咽气雾剂临床耐受性试验  

Clinical tolerability of Qiweiqingyan Aerosol with changed and unchanged pharmaceutical propellant

作　　者：胡超[1] 郑靖[1] 苗佳[1] 舒世清[1] 刘雯[1] 王颖[1] 朱晓红[1] 

机构地区：[1]四川大学华西医院Ⅰ期临床研究室,成都610041

出　　处：《中国新药杂志》2016年第13期1505-1510,共6页Chinese Journal of New Drugs

摘　　要：目的：观察健康受试者对七味清咽气雾剂临床常用剂量的耐受性,为制定临床用药方案提供依据。方法：采用随机对照双盲试验设计,45例健康受试者分入3组,每组15例,随机分配其中10例接受变更药用辅料后的七味清咽气雾剂,5例接受变更药用辅料前的七味清咽气雾剂。单次给药组给予七味清咽气雾剂3揿,多次给药低剂量和高剂量组分别给予七味清咽气雾剂每次3揿和4揿,tid,连续7 d,观察用药前后受试者生命体征的变化及不良事件。结果：单、多次给药试验组和对照组的不良反应发生情况差异均无统计学意义。变更药用辅料前后的七味清咽气雾剂最常见的不良反应为喷药部位不适,包括麻木感、异物感、刺痛、咽干、口干,其他常见不良反应有一过性胆红素和肌酸激酶同工酶（CK-MB）轻微增高等。不良反应程度轻微,未给予任何处理均能自行恢复。用药后受试者生命体征平稳。多次给药d 1的24 h动态心电图监测结果提示,给药后2~3 h心率在正常值范围内轻度减慢。结论：变更药用辅料前、后的七味清咽气雾剂均安全、耐受性良好。推荐临床给药方案可为每次3掀或4掀,tid,需要关注用药后胆红素的变化。Objective： To evaluate the tolerability of Qiweiqingyan Aerosol with changed and unchanged pharmaceutical propellant in healthy volunteers at commonly used doses,so as to provide evidence for design of therapeutic dosing regimen. Methods： A double-blind randomized controlled design was used in this trial. Fortyfive healthy volunteers were divided into 3 groups（ 1 single-dose group and 2 multi-dose groups）,with 15 in each group,among whom 10 were randomly divided into the test group（ Qiweiqingyan Aerosol with changed pharmaceutical propellant） and 5 to the control group（ Qiweiqingyan Aerosol with unchanged pharmaceutical propellant）. The subjects in the single-dose group were given Qiweiqingyan Aerosol 3 presses. The subjects in the the low and high dose multi-dose groups were respectively given Qiweiqingyan Aerosol 3 and 4 presses each time,three times a day for consecutive 7 days. The vital signs and adverse events before and after administration were observed. Results：The most common adverse reactions of Qiweiqingyan Aerosol were dicomforts at spraying site,including numbness,foreign body sensation and tingling,as well as dry throat and dry mouth. Other commom adverse reactions were transient slight increase of bilirubin and CK-MB. The adverse reactions were mild,and recovered without any treatment. There were no statistically significant differences in the incidence of adverse reactions between the test group and control group for both single-dose and multiple-doses. All vital signs were stable in the normal range afterdrug administration. On the first day of multiple-dose administration,the 24-hour Holter monitoring results showed that the heart rate slightly slowed down 2 to 3 h after each administration,but were still in the normal range.Conclusion： Both the Qiweiqingyan Aerosols with changed and unchanged pharmaceutical propellant are safe and well tolerated. The recommended therapeutic dosing regimen is 3 or 4 sprays each time,3 times a day. There is a need to pay attention to the poss

关 键 词：七味清咽气雾剂 耐受性试验 单次给药 多次给药 

分 类 号：R974[医药卫生—药品]